NCT06685523

Brief Summary

In this study, mechanical debridement group, Er:YAG laser group and diode laser group will be compared in terms of reducing peri-implant sulcus depth in the treatment of peri-implantitis.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 8, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

November 8, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 12, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 8, 2025

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2025

Completed
Last Updated

November 12, 2024

Status Verified

November 1, 2024

Enrollment Period

6 months

First QC Date

November 8, 2024

Last Update Submit

November 11, 2024

Conditions

Keywords

Er:YAG laserDebridmentperi-implantitis

Outcome Measures

Primary Outcomes (1)

  • Probing depth, clinical attachment loss

    Measurement will be made with a periodontal probe. The unit of measurement is millimetre. The primary outcome measures are interrelated.

    sixth month

Secondary Outcomes (1)

  • gingival index, plaque index, sulcus blood index

    sixth month

Study Arms (4)

Group healty

NO INTERVENTION

Mechanical debridement group

EXPERIMENTAL
Procedure: Subgingival debridement

Er:YAG laser applied group

EXPERIMENTAL
Procedure: Er:YAG laser decontamination

Diyot laser applied group

EXPERIMENTAL
Procedure: Diyot laser decontamination

Interventions

To be applied 1 times (0. days)

Mechanical debridement group

To be applied 3 times

Er:YAG laser applied group

To be applied 3 times

Diyot laser applied group

Eligibility Criteria

Age40 Years - 60 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Probing depth of 4-6 mm, bone loss of at least 2 mm on X-ray and presence of inflammatory symptoms in soft tissue
  • No systemic disease that may affect the outcome of the treatment
  • Patients with healthy periodontium or patients with completed periodontal treatment
  • Individuals at least 6 months after prosthesis loading on the implant
  • Individuals who do not require further surgery for the treatment of peri-implantitis
  • Implants with at least 2 mm keratised gingiva
  • Individuals aged 40-60 years

You may not qualify if:

  • Individuals undergoing radiation therapy
  • Individuals who smoke and drink alcohol
  • Individuals in pregnancy or lactation
  • Individuals who have received antibiotic treatment in the last three months
  • Individuals with parafunctional habits

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kırıkkale University, Faculty of Dentistry, Department of Periodontology

Kırıkkale, 71000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Four group: * Peri-implant healty * Mechanical curette * Er:YAG laser * Diyot laser
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 8, 2024

First Posted

November 12, 2024

Study Start

November 8, 2024

Primary Completion

May 8, 2025

Study Completion

May 15, 2025

Last Updated

November 12, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations